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Extension Study to Evaluate Long Term Safety of Denosumab in Subjects Undergoing ADT for Non-Metastatic Prostate Cancer

This study has been completed.
Information provided by (Responsible Party):
Amgen Identifier:
First received: February 5, 2009
Last updated: November 1, 2013
Last verified: November 2013
The purpose of this study is to describe the safety and tolerability of up to 5 years (ie, 3 years under the 20040138 Amgen study and 2 years on this study) denosumab administration as measured by adverse events, immunogenicity, and safety laboratory parameters in subjects who previously received denosumab for non-metastatic prostate cancer.

Condition Intervention Phase
Cancer Carcinoma Castrate-Resistant Prostate Cancer Prostate Cancer Tumors Drug: Denosumab Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open Label, Single Arm, Extension Study to Evaluate the Long Term Safety of Denosumab (AMG 162) in the Treatment of Bone Loss in Subjects Undergoing Androgen-Deprivation Therapy for Non-Metastatic Prostate Cancer

Resource links provided by NLM:

Further study details as provided by Amgen:

Primary Outcome Measures:
  • Overall Survival Through Month 24 [ Time Frame: 24 months ]

Enrollment: 384
Study Start Date: February 2009
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1 Drug: Denosumab
60 mg SC of Denosumab will be administered on study day 1, month 6, month 12, and month 18


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Subjects must be currently participating in the 20040138 Amgen study
  • Subjects must sign the informed consent before any study specific procedures are performed.

Exclusion Criteria

  • Subjects with any prior diagnosis of bone metastasis
  • Known hypocalcemia
  • Developed sensitivity to mammalian cell derived drug products during the 20040138 study
  • Currently receiving any investigational product other than denosumab or having received any investigational product during the 20040138 study
  • Any disorder that, in the opinion of the investigator, may compromise the ability of the subject to give written informed consent and/or comply with study procedures
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00838201

  Hide Study Locations
United States, Alabama
Research Site
Huntsville, Alabama, United States, 35801
United States, California
Research Site
Anaheim, California, United States, 92801
Research Site
Laguna Hills, California, United States, 92653
Research Site
Long Beach, California, United States, 90813
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San Bernardino, California, United States, 92404
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San Diego, California, United States, 92103
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San Diego, California, United States, 92120
Research Site
Santa Monica, California, United States, 90404
United States, Connecticut
Research Site
Middlebury, Connecticut, United States, 06762
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New Britain, Connecticut, United States, 06052
United States, Florida
Research Site
Trinity, Florida, United States, 34655
United States, Indiana
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Fort Wayne, Indiana, United States, 46825
United States, Maryland
Research Site
Greenbelt, Maryland, United States, 20770
United States, Minnesota
Research Site
Sartell, Minnesota, United States, 56377
United States, Nebraska
Research Site
Omaha, Nebraska, United States, 68114
United States, New York
Research Site
Albany, New York, United States, 12208
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Bay Shore, New York, United States, 11706
Research Site
Garden City, New York, United States, 11530
Research Site
Poughkeepsie, New York, United States, 12601
United States, Pennsylvania
Research Site
Lancaster, Pennsylvania, United States, 17604
United States, Rhode Island
Research Site
East Providence, Rhode Island, United States, 02914
United States, South Carolina
Research Site
Myrtle Beach, South Carolina, United States, 29572
United States, Texas
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Dallas, Texas, United States, 75231
United States, Virginia
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Salem, Virginia, United States, 24153
United States, Washington
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Burien, Washington, United States, 98166
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Seattle, Washington, United States, 98104
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Tacoma, Washington, United States, 98405
Canada, Alberta
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Calgary, Alberta, Canada, T2V 1P9
Canada, British Columbia
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Kelowna, British Columbia, Canada, V1Y 2H4
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Surrey, British Columbia, Canada, V3V 1N1
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Vancouver, British Columbia, Canada, V5Z 1M9
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Victoria, British Columbia, Canada, V8T 5G1
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Victoria, British Columbia, Canada, V8V 3N1
Canada, Ontario
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Barrie, Ontario, Canada, L4M 7G1
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Brantford, Ontario, Canada, N3R 4N3
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Burlington, Ontario, Canada, L7N 3V2
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Burlington, Ontario, Canada, L7S 1V2
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Guelph, Ontario, Canada, N1H 5J1
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Kingston, Ontario, Canada, K7L 3J7
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Kitchener, Ontario, Canada, N2N 2B9
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London, Ontario, Canada, N6A 4G5
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Markham, Ontario, Canada, L6B 1A1
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Newmarket, Ontario, Canada, L3X 1W1
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North Bay, Ontario, Canada, P1B 7K8
Research Site
North York, Ontario, Canada, M2J 1V1
Research Site
Oakville, Ontario, Canada, L6H 3P1
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Oshawa, Ontario, Canada, L1H 7K4
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Scarborough, Ontario, Canada, M1P 2T7
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Sudbury, Ontario, Canada, P3E 4T3
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Toronto, Ontario, Canada, M2J 1V1
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Toronto, Ontario, Canada, M4N 3M5
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Toronto, Ontario, Canada, M6A 3B5
Canada, Quebec
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Greenfield Park, Quebec, Canada, J4V 2H3
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Montreal, Quebec, Canada, H3G 1A4
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Seinajoki, Finland, 60220
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Tampere, Finland, 33520
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Balatonfured, Hungary, 8230
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Budapest, Hungary, 1036
Research Site
Budapest, Hungary, 1204
Research Site
Gyor, Hungary, 9023
Research Site
Nyiregyhaza, Hungary, 4400
Research Site
Mexico City, Distrito F, Mexico, 07760
Research Site
Mexico City, Distrito F, Mexico, 14140
Research Site
Toluca, Mexico, 50120
Research Site
Veracruz, Mexico, 91700
Research Site
Bialystok, Poland, 15-276
Research Site
Bydgoszcz, Poland, 85-171
Research Site
Lublin, Poland, 20-718
Research Site
Lublin, Poland, 20-954
Research Site
Opole, Poland, 45-086
Research Site
Siedlce, Poland, 08-110
Research Site
Warszawa, Poland, 00-416
Research Site
Warszawa, Poland, 02-781
Research Site
Wroclaw, Poland, 50-088
Sponsors and Collaborators
Study Director: MD Amgen
  More Information

Additional Information:
Responsible Party: Amgen Identifier: NCT00838201     History of Changes
Other Study ID Numbers: 20080537
Study First Received: February 5, 2009
Results First Received: July 23, 2013
Last Updated: November 1, 2013

Keywords provided by Amgen:
Androgen deprivation therapy for non-metastatic prostate cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Bone Density Conservation Agents processed this record on September 20, 2017